Esperion Nets Another Positive Late-Stage Study Under Its Belt

Summary

• Esperion Therapeutics posts positive phase 2 results in patients with elevated levevels of LDL-C who were on background therapy with an injectable PCSK9 inhibitor.
• The positive synergy between bempedoic acid and repatha may provide a path forward for other combination therapies involving PCSK9 inhibitors.
• Positive phase 3 data in a prior study proved that bempedoic acid improved clinical outcome over placebo for those already on lipid modifying therapies.
• The financials are solid as Esperion has enough cash to fund its operations well into 2020, meaning that other bempedoic acid trials will be read out before a cash raise is necessary.
• The positive outcome of adding bempedoic acid together with an injectable PCSK9 inhibitor makes Esperion an attractive acquisition target.

Recently, Esperion Therapeutics (NASDAQ:ESPR) announced positive phase 2 results in patients with hypercholesterolemia. What this entails is that the company's drug bempedoic acid can be combined with injectable PCSK9 inhibitors to improve upon a patient's clinical outcome. That's because sometimes even when these patients take a PCSK9 inhibitor alone, it does not lower their cholesterol enough to be effective. That's why I believe that this new data is solid and why Esperion Therapeutics remains a solid buy.

Phase 2 Data

The phase 2 study was to evaluate the safety and efficacy of 180 mg/day bempedoic acid in patients with hypercholesterolemia (high cholesterol) who were already taking a PCSK9 inhibitor. This entailed 59 patients being randomized to receive either bempedoic acid or placebo as an add on therapy to a PCSK9 inhibitor. The primary endpoint of the study was to determine the eight-week LDL-C lowering efficacy of bempedoic acid versus placebo while patients were on a PCSK9 inhibitor. More specifically, patients were on a background therapy of Amgen (AMGN) repatha. The results were really good, as the trial met on its primary endpoint of achieving significantly better LDL-C lowering compared to placebo. It was noted that patients treated with bempedoic acid achieved a 27% decrease in LDL levels, compared to the placebo patients who had instead seen an increase of 3% in LDL. The results are outstanding but there is something else of importance that was observed in the study. The patients treated with bempedoic acid had achieved a 34% drop in high-sensitivity C-reactive protein (hsCRP). This compares to the placebo which only achieved a 2% reduction of the hsCRP biomarker. Why is this hsCRP biomarker so important? That's because this biomarker, which deals with inflammation, is linked to heart disease. The greater the reduction observed with respect to this biomarker, the greater the reduced risk of heart disease.

Prior Data

This phase 2 study is one of the many studies that Esperion has ongoing. It has proven its hypercholesterolemia drug to work in another study as well. This was about a few weeks ago when the company reported that bempedoic acid beat out placebo in a phase 3 study treating patients who were at a high risk of atherosclerosis and where the cholesterol could not be controlled with lipid-modifying drugs. It was shown that patients treated over a 12-week period with bempedoic acid fared better than those who were given placebo. It was shown that there was a statistically significant reduction of LDL-C by 28% for those who took 180 mg of bempedoic acid. This was the primary endpoint of the study. It gave a p-value of p < 0.001. In addition, the change in baseline of those treated with bempedoic acid was 23%. Why is that important? That's because those treated in the placebo group saw an increase of 5% in LDL-C. This data paints a good picture, but there was something else that was noteworthy from the study as well. It was shown that patients treated with bempedoic acid also experienced a 33% reduction the C-reactive protein biomarker. This was compared to the placebo group, which saw an increase of the C-reactive protein by 2%. The difference in this biomarker between treatment and placebo was also statistically significant with a p-value of p <0.001.

Financials

Esperion Therapeutics has cash and cash equivalents of $273.6 million as of December 31, 2017. The company states that it is likely to end 2018 with approximately $130 to $140 million in cash. That means it will have enough cash until 2020. That is significant because it will be enough to carry Esperion through potential approvals for the combo of bempedoic acid, and bempedoic acid alone, by the first quarter of 2020. Of course, that is pending that it receives FDA approval for both of these treatments. The filing of approval for the combo deals with bempedoic acid together with Merck (MRK) Zetia (also known as ezetimibe). The NDA is expected to be filed by the first quarter of 2019.

Risks

The biggest risk with Esperion is the remaining studies. Thus far, it has done a good job with its clinical data. We will have to see how the remaining studies for bempedoic acid turn out to see what other competitive advantages the company can obtain over any potential competitors. As you see, repatha from Amgen is one competitor. Another competing product to make note of would be praluent from Sanofi (SNY) and Regeneron (REGN). This also pertains to the risk once bempedoic acid reaches the market, it remains to be seen if it will be able to outsell praluent and repatha.

Conclusion

Esperion Therapeutics has succeeded yet again in obtaining positive results by using its LDL-C lowering drug bempedoic acid. Not only has it succeeded in this phase 2 study, but it has already seen success in late-stage studies as well. What I also believe is a positive is that those patients who didn't respond well on repatha alone, were able to achieve better LDL-C lowering when bempedoic acid was added to the equation. At the very least, this to me is some evidence that a company like Amgen or another big pharmaceutical company may even want to eventually acquire Esperion. In my opinion, the future of medicine is not going to be single therapies being produced alone to treat diseases. I believe that the future of medicine will come in terms of combination therapies. We already see combination therapies being developed for immunotherapy cancer biotechs combining their drugs with PD-1 or PD-L1 therapies. The same can be said with Gilead (GILD) which has been continuously keeping its HIV franchise afloat with triple combination therapies. The same I believe will happen for LDL-C lowering therapies. Thus, the reason why I think Esperion presents itself as a potential acquisition target. That's the reason why I feel it remains a strong buy.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.